Avance Clinical: The Australian CRO for BioTechs
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Avance Clinical: The Australian CRO for BioTechs

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Yvonne Lungershausen, Chief Executive Officer, Avance ClinicalYvonne Lungershausen, Chief Executive Officer
All companies are under pressure to contain fixed costs. Both large and small pharmaceutical companies depend on service providers to perform tasks, solve problems, and improve efficiency. While drug manufacture takes a back seat in Phase I, it comes to the forefront during late-phase development. There are defined activities and industry regulations (ICH, FDA, EMEA, CDER), leading to a longer and more complicated outsourcing program. Consequently, a different regulatory strategy is necessary along with a higher level of Good Manufacturing Practices (GMP) compliance and, as regulatory scrutiny increases, the risk of a clinical hold is more probable. Along these lines, Avance Clinical—a well renowned Australian CRO, with extensive experience across every phase of clinical research, complemented with a full suite of in-house clinical research services, ensures that trials are delivered on time and budget.

"We aim to give clients unparalleled service to optimise the time and cost-effective completion of projects. It's as simple as that," adds Yvonne Lungershausen, the Chief Executive Officer at Avance Clinical. The company offers premium services in an established clinical trial ecosystem that includes world-class Investigators and Sites able to access specialised patient groups. In addition, Avance Clinical possesses over two decades of experience in offering seamless end-to-end in-house clinical research services, supporting its clients' portfolio with clinical project management, trial monitoring, local safety reporting, medical writing, data management, statistical and pharmacokinetic services, CDISC and external and internal auditing around the globe. Regarded as the Australian CRO partner of choice by Biotech companies worldwide, Avance's client portfolio extends across North America, Canada, New Zealand, Asia and Europe with these companies predominantly situated in the private biotech and pharmaceutical sector.
As one of the leading Australian CRO, Avance Clinical has an array of clinical research experience in covering prominent therapeutic areas related to Oncology, Ophthalmology, Haematology, Otorhinolaryngology (ENT), Dermatology and Pediatric/Neonatology, to name a few.

We aim to give clients unparalleled service to optimise the time and cost-effective completion of projects. It's as simple as that

Today, the Thebarton-based company has become one of Australia's leading Contract Research Organisations—facilitating quality drug development by aligning people, skills, and expertise in the pursuit of drug development for a healthier world. Furthermore, Avance is committed to providing best-in-class clinical research services with its highly-experienced team. The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.

Specialising in working with biotech companies to execute Phase 1 and Phase 2 clinical trials, Avance's service portfolio includes clinical project management, clinical trial monitoring, drug safety reporting, medical writing, data management, statistical and pharmacokinetic services, and external auditing. Approximately 96 per cent of Avance's work is supporting small to medium-sized biotechnology companies executing Phase 1 and Phase 2 trials, extending across North America, Canada, New Zealand, Europe and Asia and being accepted by all of the major regulatory agencies around the globe.

Avance Clinical has recently commended the Australian industry for exceptional COVID-19 management which indicates that Australia leads the world in maintaining clinical trials business. The company's Chief Strategy Officer, Ben Edwards presented at BIO Digital 2020 on the many benefits of running trials in Australia. Edwards has pointed out, "Approximately 96% of our work is supporting small to medium-sized biotechnology companies executing Phase 1 and Phase 2 trials. Our client base currently extends across North America, Canada, New Zealand, Europe and Asia. Australia is a well-established location for international clinical trials, and our management of the COVID-19 crisis has made it an even more attractive trials destination." This statement alone proves to be a testament to the strength of Avance's impressive COVID-19 management and its overall commitment to quality.
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Company
Avance Clinical

Headquarters
Thebarton, South Australia

Management
Yvonne Lungershausen, Chief Executive Officer

Description
Avance Clinical is a full-service contract research organisation offering a suite of clinical trial services to biotechnology and pharmaceutical companies globally. The company’s in-house services include Protocol and Report Writing, Project Management, Site Monitoring, Safety Reporting, Data Management, Statistical Services, Pharmacokinetics, CDISC datasets, QA Consulting/Auditing and Clinical Kit Management. Avance’s client centric philosophy is underpinned by responsiveness, flexibility and results driven accountability. Headquartered in South Australia, Avance Clinical has access to a wide network of clinicians and clinical research sites in both Australia and New Zealand

Avance Clinical

Avance Clinical News

Avance Clinical Contracted for Atossa Therapeutics AT-301 Nasal Spray Clinical Study, Atossa's Second COVID-19 Therapeutic Development Program

Adelaide, AUS - The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been contracted to conduct a clinical study of Atossa Therapeutics' proprietary drug candidate AT-301, to be administered by nasal spray. Avance has successfully completed multiple clinical studies of Atossa's proprietary Endoxifen.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need with a current focus on breast cancer and COVID-19.

Yvonne Lungerhausen, CEO, Avance Clinical said:

"Avance Clinical is very pleased to be working with Atossa Therapeutics again on their second COVID-19 Therapeutic Development Program. Atossa is a valued long-term client that clearly understands the excellence in clinical research available in Australia, and the many benefits of conducting studies in the region."

According to Atossa Therapeutics:

AT-301 is Atossa's proprietary formula intended for nasal administration in patients immediately following diagnosis of COVID-19 but who have not yet exhibited symptoms severe enough to require hospitalization. It is intended for at-home use to proactively reduce symptoms of COVID-19 and to slow the infection rate so that a person's immune system can more effectively fight SARS-CoV-2 (coronavirus). Atossa also intends to conduct testing to determine whether AT-301 can be used as a prophylaxis to prevent or mitigate SARS-CoV-2.

The study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups. Part A consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A. Part B is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives are to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation.

"Our AT-301 nasal spray program is being developed for COVID-19 patients who are not hospitalized, which complements our AT-H201 program being developed for COVID-19 patients on ventilators," commented Steven Quay, M.D., Ph.D., President and CEO of Atossa. "Many COVID-19 patients are infected via the nasal passage, which makes a nasal spray therapy potentially very attractive. Collectively, the components of AT-301 are believed to replicate a 'vaccine-like mechanism' to help maintain a protective mucosal barrier within the nasal cavity with anti-viral properties that may lead to lower infectivity and reduced symptoms in COVID-19 patients due to their interference with the spike protein of the virus in the nasal cavity and upper respiratory tract. We may eventually develop AT-301 as a prophylaxis to reduce risk of being infected with COVID-19. For example, it could be taken as a daily vaccine-like treatment for people at higher-risk, such as TSA workers, emergency medical professionals and hospital personnel," concluded Dr. Quay.

An application to commence the study has been submitted to the relevant institutional review board (IRB) and local regulatory authority in Australia which must be approved before commencement of the study. Pending these approvals, Atossa expects that the study will commence this quarter. Adequate and well-controlled studies to demonstrate safety and efficacy must be successfully completed and regulatory approvals must be obtained before AT-301 may be commercialized. Atossa has filed provisional patent applications on AT-301 to treat patients diagnosed with, or to prevent, COVID-19 via nasal spray.